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This is an exciting opportunity to work for a successful and expanding pharmaceutical company based in the South West area, who is seeking to recruit a Senior QA Officer to work in their Quality Department
Duties:
- Prepare and review manufacturing and testing instructions for new manufacturing sites
- Review and approve master documents related to product licences held within the group, including process validation protocols, BMRs, analytical specifications and methods
- Ensure compliance of documentation from third party manufacturers
- Liaise with and support contract manufacturing sites associated with particular products
- Review quality documentation from third party manufacturers for regulatory submission
- Undertake quality investigations (OOS, deviations, complaints) using appropriate tools
Qualification and Experience
- Bachelor’s Degree in a science field (minimum)
- Relevant experience in the pharmaceutical industry; experience in quality assurance/compliance with at least 5 years’ experience.
- A sound understanding of quality compliance, manufacturing and testing principles and process validation.
- Awareness of both the EU pharmaceutical regulatory system and EU GMP guidelines.
- Experience in prioritizing conflicting demands
- Demonstrate good interpersonal skills required to build working relationships with internal stakeholders and third party manufacturers / contractors.
- Good computer skills with standard software packages (Word, Excel etc)
- Excellent verbal and written communication skills with the ability to communicate in English in a clear and easy to understand manner
- Ability to work across cultures/countries/sites
- Dependability: team-oriented, reliable, responsible, dedicated, committed and fulfilling obligations
We can only accept applicants who are living in the UK and eligible to work without restrictions.
